BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 4140374 · Received October 3, 2014

    Report

    Report Number
    2955842-2014-05445
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE TIP COVER ACCESSORY ALLEGEDLY FELL INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, WHEN USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT, THE TIP COVER ACCESSORY HAD FALLEN OFF IN THE PATIENT. THE TIP COVER WAS COMPLETELY INTACT AND IT WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. THE PLANNED PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. CLINICAL SALES REPRESENTATIVE (CSR) REPLIED BACK WITH THE REQUESTED INFORMATION AND INDICATED THAT THE TIP COVER WAS RETRIEVED BY THE FIRST ASSIST LAP GRASPER. NO ADDITIONAL SURGICAL PROCEDURE AND NO POST-OPERATIVE TEST WERE REQUIRED TO RETRIEVE THE TIP COVER. THERE WAS NO PATIENT INJURY. THE SURGEON WAS PERFORMING COLPOTOMY WHEN THE TIP COVER FELL OFF INTO THE PATIENT AND DOES NOT KNOW WHAT CAUSED IT TO FALL OFF. THE INSTRUMENT AND THE TIP COVER WERE INSPECTED PRIOR TO USE AND THERE WERE NO PHYSICAL DAMAGES NOTED. ACCORDING TO THE SCRUB TECHNICIAN, THE TIP COVER WAS NOT OVER-INSTALLED. THE TIP COVER IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618100 TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-14

    Patients

    Seq Age Sex Outcome Treatment
    1